EP0783874B1 - Gefässprothese - Google Patents

Gefässprothese Download PDF

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Publication number
EP0783874B1
EP0783874B1 EP97200644A EP97200644A EP0783874B1 EP 0783874 B1 EP0783874 B1 EP 0783874B1 EP 97200644 A EP97200644 A EP 97200644A EP 97200644 A EP97200644 A EP 97200644A EP 0783874 B1 EP0783874 B1 EP 0783874B1
Authority
EP
European Patent Office
Prior art keywords
stent
stent assembly
stents
engaging portion
prosthesis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP97200644A
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English (en)
French (fr)
Other versions
EP0783874A3 (de
EP0783874A2 (de
Inventor
George Goicoechea
John Hudson
Claude Mialhe
Andrew Harold Cragg
Michael David Dake
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Original Assignee
Boston Scientific Technology Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27442931&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0783874(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boston Scientific Technology Inc filed Critical Boston Scientific Technology Inc
Priority to EP97200644A priority Critical patent/EP0783874B1/de
Publication of EP0783874A2 publication Critical patent/EP0783874A2/de
Publication of EP0783874A3 publication Critical patent/EP0783874A3/de
Application granted granted Critical
Publication of EP0783874B1 publication Critical patent/EP0783874B1/de
Priority to GR20000400813T priority patent/GR3033211T3/el
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/852—Two or more distinct overlapping stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
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    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

Definitions

  • the present invention relates to a stent assembly comprising stent joining means for joining two endoluminal stents one to the other to define a continuous lumen through the two endoluminal stents.
  • An endoluminal stent is used to provide a prosthetic intraluminal wall e.g. in the case of a stenosis to provide an unobstructed conduit for blood in the area of the stenosis.
  • An endoluminal prosthesis comprising a stent which carries a prosthetic graft layer of fabric is used e.g. to treat an aneurysm by removing the pressure on a weakened part of an artery so as to reduce the risk of embolism, or of the natural artery wall bursting.
  • a stent or endoluminal prosthesis is implanted in a blood vessel at the site of a stenosis or aneurysm by so-called “minimally invasive techniques” in which the stent is compressed radially inwards and is delivered by a catheter to the site where it is required through the patient's skin or by a “cut down” technique in which the blood vessel concerned is exposed by minor surgical means.
  • minimally invasive techniques in which the stent is compressed radially inwards and is delivered by a catheter to the site where it is required through the patient's skin or by a “cut down” technique in which the blood vessel concerned is exposed by minor surgical means.
  • US-A-4733665 discloses an expandable intraluminal graft which is constituted by a tubular member formed from a plurality of intersecting elongate members which permit radial expansion and compression of the stent.
  • US-A-5064435 discloses a body implantable stent consisting of two or more generally tubular co-axially and slidably connected stent segments.
  • the stent is elastically deformed to a reduced radius when deployed, and when released after positioning, self-expands radially into contact with a tissue wall segment defining a blood vessel or other body cavity As each stent segment expands radially, it contracts in the axial direction. Such contraction is accommodated by a reduction in the length of medial regions where adjacent stent segments overlap; thus maintaining the overall length of the stent.
  • proximal shall mean “nearest to the heart,” and the term “distal” shall mean “furthest from the heart.”
  • the said other stent may include a proximal male engaging portion; and said one stent may include a distal female cooperating portion.
  • the male engaging portion may be flared radially outwardly towards its extremity, and the female cooperating portion may be tapered radially inwardly towards its extremity.
  • the male engaging portion may comprise a frustoconical wall which flares outwardly towards its longitudinal extremity; the female cooperating portion may comprise a frustoconical wall which tapers radially inwardly towards its longitudinal extremity.
  • said male engaging and female cooperating portions may be substantially untapered; they may be substantially cylindrical.
  • the male engaging portion of the other stent may be resiliently compressible in a radially inwards direction such that in the radially compressed state it is capable of self-reexpansion to engage in the female cooperating portion.
  • each of said stents may be resiliently compressible.
  • the one stent may be delivered in a radially compressed state by using a catheter; when the one stent is located at the site of use, the catheter may be withdrawn thereby allowing the one stent to re-expand to engage the endoluminal surface of the blood vessel.
  • the other stent may then be delivered percutaneously or by a "cut down" technique to a site distal of the one stent such that the male engaging portion of the other stent in the radially compressed state is entered into the expanded female cooperating portion of the one stent; the catheter may then be withdrawn allowing the other stent to re-expand such that the male engaging portion engages in the female cooperating portion of the one stent.
  • the proximal end of said one stent may be flared radially outwardly towards its extremity to engage the endoluminal surface of the artery thereby to resist longitudinal movement of the one stent in service.
  • Each of the stents may comprise a sinuous wire formed into a tubular configuration.
  • the sinuous and tubular configurations may be imparted to the wire by winding it on a mandrel.
  • each stent may be made from a shape memory nitinol (nickel-titanium) wire which may be wound on to the mandrel to form the stent in a tubular configuration of slightly greater diameter than the diameter of the blood vessel in which the stent is intended to be used.
  • the stent may be annealed at an elevated temperature and then allowed to cool in air so that the nitinol wire "remembers" the configuration in which it was wound on the mandrel.
  • Said nitinol wire may be type "M" nitinol wire which is martensitic at temperatures below about 13°C and is austenitic at temperatures above about 25°C; it will be appreciated therefore that the type "M" wire will be austenitic at body temperature of 37°C.
  • the annealing may be conducted at about 500°C or more for at least about 60 minutes; after cooling the wire may be immersed in cold water to facilitate removal of the wire from the mandrel with the wire in its maleable martensitic form.
  • the cold water may have temperature of less than about 10°C; the wire may be immersed for about 5 minutes or more.
  • nitinol wire is "super elastic" in its austenitic state; the radial outward force exerted by the stent on the wall of the blood vessel in use is therefore substantially constant irrespective of the diameter of the vessel and the expanded stent.
  • the wire may have a helical configuration as disclosed in EP-A-0556850.
  • the wire may be of a configuration in which the wire forms a plurality of hoops such that the plane of the circumference of each hoop is substantially perpendicular to the longitudinal axis of the stent.
  • Each hoop may comprise a substantially complete turn of the wire having a sinuous configuration; optionally, as each hoop is completed, the point of winding the wire may be displaced longitudinally with respect to the winding axis to form the next hoop. When the next hoop is complete, the point of winding is moved further longitudinally with respect to the winding axis to form the next succeeding hoop and so on.
  • an advantage of this arrangement is that the planes of the hoops are not skewed with respect to the longitudinal axis of the stent; the longitudinal ends of the stent are "square" to said longitudinal axis, so that when the stent is caused or allowed to expand in situ there is substantially no twisting of the stent as it shortens in length. It will be appreciated that this represents a significant advantage, as in areas of stenosis or aneurysm it is desirable to minimize the movement of the stent within the blood vessel so as to reduce the potential trauma to the patient.
  • the stents whether of the helical or perpendicular variety, also comprise a securing means for securing an apex of the sinuous wire in one hoop to a juxtaposed apex of a neighboring hoop so that each hoop is supported by its neighbors.
  • the securing means may comprise a loop element of a suture material, for example, to tie the juxtaposed apices together; the loop element may also comprise a loop formed of a thermoplastics material such, for example, as polypropylene.
  • the securing means may be a bead formed of a thermoplastic material around juxtaposed apices.
  • the securing means may be a loop, ring, or staple formed of wire such as nitinol.
  • the male engaging portion and female cooperating portion, of the interengaging stents of this invention may be formed separately from the remainder of the respective non-engaging portions of these stents and then the engaging and non-engaging portions secured to one another by securing means.
  • At least one of the stents of the stent assembly of the present invention may carry a tubular graft layer formed from a biocompatible fabric in juxtaposition with the stent; the combined stent and graft layer constituting an endoluminal prosthesis.
  • the graft layer may be disposed externally of the stent; it will be appreciated however that in some embodiments the graft layer may be disposed internally of the stent.
  • the graft layer on the one or other stent may be secured to the stent by loop elements such, for example, as loops of polypropylene.
  • the biocompatible fabric may be a polyester fabric or a polytetrafluoroethylene fabric; typically said fabric may be woven or a warp knitted polyester fabric. In some embodiments the woven or a warp knitted fabric may be formed in a seam-free bifurcated configuration as a sleeve for a bifurcated stent.
  • the male engaging portion of the other stent and the female cooperating portion of the one stent may be left uncovered.
  • the fabric graft layer may extend to the proximal extremity on the external surface of the male engaging portion, and may be folded over the distal extremity of the female cooperating portion to form an inner sleeve; in use the external fabric of the male engaging portion may butt against the folded over portion of the fabric internally of the female cooperating portion to form a substantially blood tight seal.
  • prosthesis of the present invention may be introduced to the site of use percutaneously or by "cut down" techniques.
  • Either of the stents of the prosthesis may be provided on its external surface with circumferentially spaced wire barbs or hooks adapted to engage in the endoluminal surface of the host artery to resist longitudinal movement or slippage of the stent in use.
  • the barbs or hooks may be disposed on part of the stent which is provided with a fabric graft layer such that in use the points of the artery which are engaged by the barbs or hooks are covered by the fabric graft.
  • the male engaging portion for the other stent may be provided with circumferentially spaced hooks or barbs on its external surface to engage the internal surface of said female cooperating portion, thereby to reinforce the connecting means against longitudinal separation of the stents one from the other in the service.
  • the present invention therefore provides a stent assembly comprising connecting means for connecting two stents longitudinally one to the other. It will be appreciated that this represents a significant step forward in the art as it allows the provision of a bifurcated endoluminal prosthesis for use in juxtaposition e.g. with arterial bifurcations without requiring by-pass surgery to connect one of the branched arteries to the other branched artery.
  • the invention makes it possible to provide a bifurcated endoluminal prosthesis which can be positioned in an artery in juxtaposition with a bifurcation to extend into one of the branched arteries; the bifurcated prosthesis can be connected to another prosthesis which extends into the other branched artery.
  • the prostheses can be delivered percutaneously or by "cut down" methods and connected together in situ thereby to provide effective treatment of an angeological disease such, for example, as an aneurysm or a stenosis which extends across a bifurcation in a blood vessel without the need for by-pass surgery.
  • Figure 1a is a front view of a bifurcated intraluminal stent constituting part of an endoluminal prosthesis.
  • Figure 1b is a front view of another stent which is adapted to be connected to the bifurcated stent of Figure 1a.
  • Figure 2(a) is a side view of part of the bifurcated stent of Figure 1a opened up to show its construction.
  • Figure 2(b) is a side view of an exemplary mandrel used to form the part of the bifurcated stent shown in Figure 2(a).
  • Figure 3 is a side view of another part of the bifurcated stent of Figure 1a opened up to show its construction.
  • Figure 4(a) is a side view of yet another part of the bifurcated stent of Figure 1a opened up to show its construction.
  • Figures 4(b)-4(f) are partial exploded views of the exemplary stent of Figure 4(a) illustrating alternative means for securing juxtaposed apices according to the present invention.
  • Figure 5 is a schematic perspective view of a bifurcated endoluminal prosthesis.
  • Figure 6 is a schematic view of another bifurcated endoluminal prosthesis.
  • Figure 7 is a schematic view of yet another bifurcated endoluminal prosthesis.
  • a bifurcated stent which is indicated at 10 in Figure la comprises a wire skeleton which is constructed in four separate parts, namely a proximal part 12, a first frustoconical part 14, a first distal part 16 and a second frustoconical part 18
  • Said bifurcated stent 10 carries a fabric graft layer ( Figures 5, 6, and 7) for use as an endoluminal prosthesis e.g. in the infrarenal portion of a mammalian aorta in juxtaposition with the bifurcation of the common iliac arteries.
  • bifurcated stents for use in different parts of the angeological system and for different mammals can be constructed by varying the dimensions of the stent accordingly.
  • diseases that can be treated using the apparatus of the present invention include aneurysm, stenosis, and occlusion.
  • Each of the four parts of the bifurcated stent 10 is made in substantially the same way by winding a shape memory nitinol wire, typically nitinol type M wire, onto a mandrel 46.
  • nitinol wire type M wire typically having a diameter of 0.46mm (0.018") is wound around mandrel 46 to form a plurality of hoops 20.
  • the winding surface of mandrel 46 is provided with a plurality of upstanding pins 47 disposed in a zig-zag pattern for each of the hoops 20 so that in each hoop 20 the nitinol wire follows a sinuous path to define a plurality of circumferentially spaced apices 22.
  • Each hoop 20 is wound onto mandrel 46 such that the plane of the circumference of each hoop 20 is substantially perpendicular to the longitudinal axis of the mandrel.
  • the point of winding of the nitinol wire is displaced longitudinally with respect to the axis of mandrel 46 to form the next successive hoop 20b
  • the stent shown in Figure 2(a) is the stent formed on mandrel 46 shown in Figure 2(b) after cutting the stent longitudinally and rotating it 45 degrees to show the construction of the stent.
  • the proximal part of the bifurcated stent of Figure 1a is formed on the mandrel with a diameter of about 24mm and a length in the longitudinal direction of about 55mm. From Figures 1(a), 2(a), and 2(b) it will be noted that the proximal part 12 is constituted by three hoops 20 of unit width at the proximal end 24 of the proximal part 12, two intermediate hoops 25 of twice unit width and, at its distal end 26, by a single hoop 20 of unit width. In the illustrated embodiment, intermediate hoops 25 have a plurality of offsets 25a. Offsets 25a are formed when the wire is passed around pins 47 on mandrel 46. Offsets 25a add stability to the stent. When the nitinol wire has been wound onto mandrel 46, the nitinol wire is annealed at an elevated temperature and then allowed to cool.
  • the wire is annealed at a temperature of about 500°C for 60 minutes and is then allowed to cool in air.
  • the purpose of the annealing is so that the nitinol wire in its austenitic form "remembers" its configuration as wound on mandrel 46; it will be appreciated therefore that other temperatures and durations for the annealing are included within the present invention provided the nitinol wire "remembers" its wound configuration.
  • securing means 99 which are, in this example, 0.003" polypropylene filaments.
  • securing means 99 which are, in this example, 0.003" polypropylene filaments.
  • apex 22 of each hoop 20 which has a juxtaposed apex of a neighboring hoop 20 is tied to the juxtaposed apex 22. It will be appreciated, however, that alternatively only some of the juxtaposed apices 22 may be secured in this way.
  • the securing means may comprise a loop element 99a of a suture material, for example, to tie the juxtaposed apices together, as shown in Figure 4(b).
  • the securing means may also comprise bead 99b formed of a thermoplastic material around juxtaposed apices, as shown in Figure 4(c).
  • the securing means may be a loop 99c, ring 99d, or staple 99e formed of wire such as nitinol, as shown in Figures 4(d), 4(e), and 4(f) respectively.
  • the first and second frustoconical parts 14, 18 of the skeleton shown in the figures are formed in substantially the same way as the proximal part 12 by winding nitinol wire onto a mandrel and then annealing the wire before removing it from the mandrel.
  • the first and second frustoconical parts 14, 18 are each constituted by three hoops 20 of unit width.
  • the mandrel is tapered such that the proximal end of each of the frustoconical parts 14, 18 is formed with a diameter of about 12mm and the distal end 32 of each is formed with a diameter of about 9mm.
  • the overall length of each of the exemplary frustoconical parts 14, 18 is about 18mm.
  • the wire used for the frustoconical parts 14, 18 is nitinol type M wire having a diameter of 0.28mm (0.011"). Juxtaposed apices 22 of each of the frustoconical parts 14, 18 are tied together using 0.03" polypropylene filaments as described above.
  • the first and second frustoconical parts 14, 18 are secured to the distal end 26 of the proximal part 12 of the stent 10 in transversely spaced relation as shown in Figure la by securing the apices 22 of the hoop 20 forming the wider proximal end 30 of each of the frustoconical parts 14, 18 to juxtaposed apices 22 of the hoop 20 on the distal end 26 of the proximal part 12.
  • the first distal part 16 of the bifurcated stent 10 is formed by winding nitinol type M wire typically having a diameter of 0.28mm (0.011") onto a mandrel to form twelve longitudinally spaced hoops 20 as shown in Figure 4; the first distal part has an overall length of about 66mm and a uniform diameter of about 9mm.
  • the proximal end 34 of the distal part 16 is secured to the narrower distal end 32 of the first frustoconical part 14 by tying each apex 22 on the proximal end 34 of the first distal part 16 to a juxtaposed apex on the distal end 32 of the first frustoconical part 14 using, in this embodiment, 0.003" polypropylene filaments.
  • the proximal part 12, the first and second frustoconical parts 14, 18, and the first distal part 16 are each covered with a tubular graft layer of a biocompatible woven fabric such, for example, as a plain woven fabric made from 30 or 40 denier polyester.
  • the tubular fabric layers may be attached to the proximal and distal parts 12, 16 of the stent 10 by stitching with, for example, 0.003" polypropylene filaments around the apices 22 of the underlying skeleton.
  • the proximal part 12 of the wire skeleton may be provided with a plurality of circumferentially spaced hooks or barbs 43 which project through the tubular fabric layer to engage in the endoluminal surface of a host artery in service.
  • each turn 20 of the wire skeleton of the stent 10 allows the prosthesis to be compressed resiliently radially inwards so that it can be received in a catheter e.g. a 16 or 18 French catheter for percutaneous or cut down delivery, e.g. to an intraluminal site in the infrarenal section of the aortic artery.
  • a catheter e.g. a 16 or 18 French catheter for percutaneous or cut down delivery, e.g. to an intraluminal site in the infrarenal section of the aortic artery.
  • Larger diameter catheters up to, e.g., 20 French, may be used to deliver the prosthesis using "cut down" procedures.
  • An x-ray opaque marker may be attached to one or more ends of a stent so that the delivery of the stent can be monitored using x-rays.
  • a radiopaque marker may typically comprise a gold or platinum wire 17 crimped onto an end of stent 16.
  • the radiopaque marker may be a tube 17a disposed around a length of wire on the stent, also as shown in Figure 4(a).
  • the marker is secured to the stent in line with the distal stent portion so that the distal stent portion can be aligned with and inserted into one of the branched arteries in situ.
  • the bifurcated endoprosthesis is positioned in the infrarenal section of the aortic artery in juxtaposition with the bifurcation of the common iliac arteries such that the first distal part 16 of the prosthesis extends into one of the common iliac arteries.
  • the catheter is then withdrawn allowing the stent 10 to re-expand towards its configuration as wound on the mandrel in which it was annealed until the stent engages the endoluminal surface of the host artery.
  • the barbs or hooks engage the endoluminal surface of the host artery to resist longitudinal displacement or slipping of the prosthesis in use.
  • blood can flow from the aortic artery into the proximal part 12 of the prosthesis from where it can flow into the one common iliac artery through the frustoconical part 14 and the first distal part 16 and also into the other common iliac artery through the second frustoconical part 18.
  • a second prosthesis comprising a second stent 40 as shown in Figure 1b is used.
  • the second stent 40 includes a wire skeleton comprising a proximal frustoconical part 42 and a distal part 44.
  • the distal part 44 of the second stent 40 also may be covered with a tubular graft layer of a biocompatible fabric such, for example, as polyester or polytetrafluoroethylene fabric.
  • the frustoconical proximal part 42 is constructed in the same way as the frustoconical parts 14, 18 of the bifurcated stent 10; the distal part 44 is constructed in the same way as the distal part 16 of the bifurcated stent 10.
  • the distal end of the frustoconical proximal part 42 is secured to the proximal end of the distal part 44 by securing juxtaposed apices using polypropylene filaments as described above.
  • the second prosthesis is compressed radially inwards and is received in a catheter for percutaneous or "cut down" delivery to the other common iliac artery.
  • the frustoconical proximal part 42 is guided, in the radially compressed state, into the second frustoconical part 18 of the bifurcated stent 10.
  • the catheter is then withdrawn allowing the second stent 40 to re-expand towards its remembered configuration, until the distal part 44 engages the endoluminal surface of the other common iliac artery, and the outer surface of the frustoconical proximal part 42 engages the interior surface of the second frustoconical part 18 of the bifurcated stent 10.
  • radiopaque markers may be used to align distal portion 44 properly with proximal portion 12.
  • the frustoconical proximal part 42 may be formed with circumferentially spaced barbs or hooks 43, as shown in Figure 1b, which engage in the wire skeleton of the second frustoconical part 18 of the bifurcated stent 10.
  • barbs 43 When barbs 43 are on proximal portion 12, they engage the inner wall of the artery.
  • the tapered configurations of the second frustoconical part 18 of the bifurcated stent 10 and of the proximal frustoconical part 42 of the second stent 40 are such that in the fitted position as described, the stents are locked together to resist longitudinal separation in service. Barbs or hooks on the second stent 40 and/or on frustoconical proximal part 42 help to resist such longitudinal separation.
  • FIG. 5 Another bifurcated endoluminal prosthesis 50 as shown in Figure 5 includes a bifurcated stent comprising a proximal portion 52 which tapers radially inwardly from its proximal end 54 to its distal end 56, and first and second transversely spaced frustoconical distal portions 58, 60 which are secured to the distal end 56 of the proximal portion 52; the proximal portion 52 is covered with a tubular graft layer of a biocompatible fabric 62.
  • the prosthesis In use the prosthesis is delivered percutaneously or by "cut down" methods to an artery in juxtaposition with an arterial bifurcation; blood can flow through the frustoconical proximal portion 52 into each of the branched arteries through the first and second distal frustoconical portions 58, 60.
  • a separate prosthesis comprising a stent of the type shown in Figure 1b referred to above covered with fabric is connected to the bifurcated prosthesis 50 by inserting and re-expanding the proximal end of such a separate prosthesis in one or both of the distal frustoconical portions 58, 60 of the prosthesis 50 for engagement therein.
  • FIG. 6 shows a bifurcated endoluminal prosthesis 70 having a proximal portion 72 which is secured at its distal end 74 to two transversely spaced frustoconical intermediate portions 76, 78.
  • One of said frustoconical intermediate portions 76 is secured at its distal end to an elongate distal portion 80.
  • the proximal end 82 of the proximal portion 72 is flared radially outwards towards its proximal end 82 to engage the intraluminal surface of the host blood vessel in service.
  • the entire endoprosthesis is covered with a fabric graft layer as shown in Figure 6, said graft layer is carried externally of the wire skeleton and is folded over the distal extremity 84 of the other frustoconical intermediate portion 78 to form an internal lining in said other frustoconical intermediate portion 78.
  • Said other frustoconical intermediate portion 78 constitutes a female cooperating portion in accordance with the present invention which is adapted to receive a male engaging portion of another prosthesis as indicated at 86 in Figure 6.
  • Said other prosthesis 86 includes a frustoconical proximal portion 88 which constitutes the male engaging portion and an elongate distal portion 90.
  • the whole of the other prosthesis 86 is covered with a fabric graft layer as shown in Figure 6.
  • the male engaging portion 88 of the other prosthesis 86 is entered into and engaged with the female cooperating portion 78 of the bifurcated prosthesis 70 in situ in the manner herein before described.
  • the fabric layer on the male engaging portion 88 butts face-to-face on the folded over portion of the fabric layer disposed internally of the female cooperating portion 78 to form a substantially blood-tight seal therewith.
  • a bifurcated endoluminal prosthesis 91 has a generally cylindrical proximal portion 92; said proximal portion 92 is connected at its distal end 93 to an elongate, generally cylindrical distal portion 94. Said proximal portion 92 is also connected at its distal end 93 to a generally cylindrical intermediate portion 95 which is secured in transversely spaced relation to the elongate distal portion 94 Said cylindrical intermediate portion 95 constitutes a female cooperating portion which is adapted to receive a generally cylindrical male engaging portion of a second elongate prosthesis (not shown). The male engaging portion is equipped with circumferentially spaced external barbs to engage in the female cooperating portion in service. As shown in Figure 7, the whole of the bifurcated prosthesis 91 is covered with an external fabric graft layer save for a flared portion 96 towards the proximal end 97 of the proximal portion 92.

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Claims (25)

  1. Stent-Anordnung, bestehend aus zwei endoluminalen Stents und Stentverbindungsmitteln zum Verbinden von zwei endoluminalen Stents miteinander, um einen zusammenhängenden Hohlraum durch die beiden Endoluminal-Stents zu schaffen, wobei die Stentverbindungsmittel einen weiblichen Anschlußbereich (18;78;95) an einem der Endoluminal-Stents und einen männlichen Eingreifbereich (42;88), der radial nach innen zusammenpreßbar ist, an dem anderen der Endoluminal-Stents aufweist, dadurch gekennzeichnet, daß der männliche Eingreifbereich so ausgestaltet ist, daß er sich in dem weiblichen Anschlußbereich entfaltet und eingreift, nachdem sich der weibliche Anschlußbereich entfaltet hat:
    Wobei der männliche Eingreifbereich (42;88) in einem radial kompressierten Zustand in den weiblichen Anschlußbereich (78;95) eingeführt werden kann und anschließend in dem weiblichen Anschlußbereich dazu veranlaßt oder es ermöglicht wird, sich zu expandieren;
    die Anordnung so ausgelegt ist, daß der männliche Eingreifbereich und der weibliche Anschlußbereich dabei so ineinander greifen, um eine Bewegung in Längsrichtung zu verhindern, daß eine Trennung der beiden Endoluminal-Stents voneinander verhindert wird.
  2. Stentanordnung gemäß Anspruch 1, wobei der andere Stent einen proximalen männlichen Eingreifbereich aufweist.
  3. Stentanordnung gemäß Anspruch 1 oder 2, wobei der eine Stent einen distalen weiblichen Anschlußbereich aufweist.
  4. Stentanordnung gemäß Anspruch 1, 2 oder 3, wobei der männliche Eingreifbereich radial nach außen in Längsrichtung aufgeweitet ist.
  5. Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei der männliche Eingreifbereich eine frustokonikale Wand umfaßt, die sich nach außen aufweitet, in Richtung ihrer Längserstreckung.
  6. Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei der weibliche Eingreifbereich eine frustokonikale Wand aufweist, die sich radial nach innen verjüngt in Richtung ihrer Längserstreckung.
  7. Stentanordnung gemäß Anspruch 1, 2 oder 3, wobei der männliche Eingreifbereich und der weibliche Anschlußbereich sich im wesentlichen nicht verjüngen.
  8. Stentanordnung gemäß Anspruch 1, 2, 3 oder 7, wobei der männliche Eingreifbereich und der weibliche Anschlußbereich im wesentlichen zylindrisch sind.
  9. Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei der männliche Eingreifbereich so nachgiebig zusammenpreßbar in nach innen gerichteter Richtung ist, daß der männliche Eingreifbereich in einem radial zusammengedrückten Zustand in der Lage ist, sich selbst zu reexpandieren, um in den weiblichen Anschlußbereich einzugreifen.
  10. Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei jeder der Stents nachgiebig zusammendrückbar ist.
  11. Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei das proximale Ende des einen Stents radial nach außen gerichtet in Längsrichtung aufgeweitet ist, um mit der endoluminalen Oberfläche des Blutgefäßes einzugreifen und, um eine Längsbewegung des einen in Betrieb genommenen Stents zu verhindern.
  12. Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei jeder Stent einen sinusförmigen Draht, der in eine röhrenartige Konfiguration geformt ist, aufweist.
  13. Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei der Stent aus einem Form-Gedächtnis-Nitinol (Nickel/Titan) - Draht geformt ist.
  14. Stentanordnung gemäß einem der Ansprüche 12 oder 13, wobei jeder der stentformenden Drähte eine Vielzahl von Bändern (20) bildet, so daß die Fläche des Umfangs jedes einzelnen Bandes im wesentlichen rechtwinklig zu der Längsachse des jeweiligen Stents verläuft.
  15. Stentanordnung gemäß Anspruch 14, wobei jedes Band eine im wesentlichen vollständige Windung des Drahtes umfaßt.
  16. Stentanordnung gemäß Anspruch 14 oder 15, wobei die Fläche des Umfangs des Bandes an jedem Längsende des Stents rechtwinklig zu der Längsachse des jeweiligen Stents verläuft.
  17. Stentanordnung gemäß einem der Ansprüche 14 bis 16, bestehend weiterhin aus einem Sicherungsmittel (99) zum Sichern eines Scheitels (22) des sinusförmigen Drahtes in einem Band zu einem benachbarten Scheitel eines benachbarten Bandes, so daß jedes Band durch seinen Nachbarn unterstützt wird.
  18. Stentanordnung gemäß Anspruch 17, wobei die Sicherungsmittel Schleifenelemente (99c) aufweisen, um die benachbarten Scheitel aneinander zu binden.
  19. Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei der andere Stent und der eine Stent aus Form-Gedächtnis-Legierungen bestehen.
  20. Endoluminale Prothese mit einer Stentanordnung gemäß einem der vorhergehenden Ansprüche, wobei zumindest eine des einen und anderen Stents eine Graft-Schicht aufweist.
  21. Prothese gemäß Anspruch 20, wobei die Graft-Schicht entweder extern oder intern auf zumindest einer der weiblichen Anschlußbereiche und dem männlichen Eingreifbereich angeordnet ist.
  22. Prothese gemäß Anspruch 20 oder 21, wobei die Graft-Schicht intern auf dem weiblichen Anschlußbereich angeordnet ist.
  23. Prothese gemäß Anspruch 20, 21 oder 22, wobei die Graft-Schicht extern auf dem männlichen Anschlußbereich angeordnet ist.
  24. Prothese gemäß einem der Ansprüche 20 bis 23, wobei eine Graft-Schicht zwischen dem weiblichen Anschlußbereich und dem männlichen Eingreifbereich angeordnet ist, um eine im wesentlichen blutdichte Abdichtung zu bilden.
  25. Prothese oder Stentanordnung gemäß einem der vorhergehenden Ansprüche, der weiterhin einen radiographischen Marker aufweist, der zumindest auf einem Stent angeordnet ist, um das Ausrichten des Stents oder die Insertion des männlichen Anschlußbereichs in den weiblichen Anschlußbereich zu unterstützen.
EP97200644A 1994-02-09 1995-02-06 Gefässprothese Expired - Lifetime EP0783874B1 (de)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP97200644A EP0783874B1 (de) 1994-02-09 1995-02-06 Gefässprothese
GR20000400813T GR3033211T3 (en) 1994-02-09 2000-04-13 Vascular prosthesis

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
EP94400284 1994-02-09
EP94400284 1994-02-09
EP94401306 1994-06-10
EP94401306 1994-06-10
US31288194A 1994-09-27 1994-09-27
US312881 1994-09-27
US08/317,763 US5609627A (en) 1994-02-09 1994-10-04 Method for delivering a bifurcated endoluminal prosthesis
US317763 1994-10-04
EP95910920A EP0759729B1 (de) 1994-02-09 1995-02-06 Prothese für körperliche gänge
EP97200644A EP0783874B1 (de) 1994-02-09 1995-02-06 Gefässprothese

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EP95910920A Division EP0759729B1 (de) 1994-02-09 1995-02-06 Prothese für körperliche gänge
EP95910920.8 Division 1995-08-17

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EP0783874A2 EP0783874A2 (de) 1997-07-16
EP0783874A3 EP0783874A3 (de) 1999-01-27
EP0783874B1 true EP0783874B1 (de) 2000-04-12

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EP95910920A Expired - Lifetime EP0759729B1 (de) 1994-02-09 1995-02-06 Prothese für körperliche gänge
EP97200644A Expired - Lifetime EP0783874B1 (de) 1994-02-09 1995-02-06 Gefässprothese
EP97200642A Expired - Lifetime EP0782841B1 (de) 1994-02-09 1995-02-06 Einführungswerkzeug für endoluminale Prothese mit endoluminaler Prothese
EP03104282A Withdrawn EP1433438A3 (de) 1994-02-09 1995-02-06 Endoluminale Prothese mit röntgenopaken Markierungen
EP97200643A Expired - Lifetime EP0783873B1 (de) 1994-02-09 1995-02-06 Bifurkations-Stent Fabrikat

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EP95910920A Expired - Lifetime EP0759729B1 (de) 1994-02-09 1995-02-06 Prothese für körperliche gänge

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EP97200642A Expired - Lifetime EP0782841B1 (de) 1994-02-09 1995-02-06 Einführungswerkzeug für endoluminale Prothese mit endoluminaler Prothese
EP03104282A Withdrawn EP1433438A3 (de) 1994-02-09 1995-02-06 Endoluminale Prothese mit röntgenopaken Markierungen
EP97200643A Expired - Lifetime EP0783873B1 (de) 1994-02-09 1995-02-06 Bifurkations-Stent Fabrikat

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US (13) US5609627A (de)
EP (5) EP0759729B1 (de)
JP (5) JPH09511160A (de)
AT (4) ATE191628T1 (de)
AU (3) AU693527B2 (de)
CA (3) CA2604811C (de)
DE (10) DE29521776U1 (de)
DK (4) DK0783874T3 (de)
ES (4) ES2219723T3 (de)
GR (3) GR3033133T3 (de)
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WO (1) WO1995021592A1 (de)

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US8317854B1 (en) 1994-06-08 2012-11-27 Medtronic Vascular, Inc. Apparatus and methods for endoluminal graft placement
US6508835B1 (en) 1998-12-11 2003-01-21 Endologix, Inc. Endoluminal vascular prosthesis
US8672989B2 (en) 2008-02-22 2014-03-18 Endologix, Inc. Apparatus and method of placement of a graft or graft system
US9149381B2 (en) 2008-02-22 2015-10-06 Endologix, Inc. Apparatus and method of placement of a graft or graft system
US8945202B2 (en) 2009-04-28 2015-02-03 Endologix, Inc. Fenestrated prosthesis
US10603196B2 (en) 2009-04-28 2020-03-31 Endologix, Inc. Fenestrated prosthesis
US8118856B2 (en) 2009-07-27 2012-02-21 Endologix, Inc. Stent graft
US8821564B2 (en) 2009-07-27 2014-09-02 Endologix, Inc. Stent graft
US9393100B2 (en) 2010-11-17 2016-07-19 Endologix, Inc. Devices and methods to treat vascular dissections
US8808350B2 (en) 2011-03-01 2014-08-19 Endologix, Inc. Catheter system and methods of using same
US9549835B2 (en) 2011-03-01 2017-01-24 Endologix, Inc. Catheter system and methods of using same

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US5683450A (en) 1997-11-04
US8192482B2 (en) 2012-06-05
US5716365A (en) 1998-02-10
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ATE188604T1 (de) 2000-01-15
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US5693086A (en) 1997-12-02
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US5609627A (en) 1997-03-11
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EP0783873A3 (de) 1999-01-27
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WO1995021592A1 (en) 1995-08-17
US20020019659A1 (en) 2002-02-14
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US5800508A (en) 1998-09-01
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